Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome (mHealth)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03027258|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Sickle Cell Disease Hepatitis B||Other: mHealth||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a "smart card." A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant.
- Reach [ Time Frame: 6 months ]Reach will be calculated as: the proportion of enrolled pregnant women relative to eligible pregnant women in the study catchment area.
- Effectiveness [ Time Frame: 6 months ]Effectiveness will be determined by assessing the impact of the mHealth platform on key outcomes such as screening for HIV, HBV, and sickle cell genotype, and health care utilizations for follow up visits. This will be measured by calculating the percentage of pregnant women that used the "smart card" at the point-of-delivery.
- Adoption [ Time Frame: 6 months ]Adoption rates will be calculated using the proportion of interested health care settings to the total number eligible for participation.
- Acceptability [ Time Frame: 6 months ]The proportion of enrolled pregnant women who accept to use the smart card for their health care services
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027258
|Contact: Echezona Ezeanolue, MD, MPHfirstname.lastname@example.org|
|Contact: Semiu O Gbadamosi, MD, MPHemail@example.com|
|Catholic Caritas Foundation||Recruiting|
|Makurdi, Benue, Nigeria|
|Contact: John Olawepo, MD, MSc +234-805 564 8788 firstname.lastname@example.org|
|Principal Investigator: Echezona Ezeanolue, MD, MPH|